MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 2L 8 FR; CATHETER INTRAVASCULAR THERAPE

Catalog Number ASK-42802-TGH1

Device Problem Biocompatibility (2886)

Patient Problems Anaphylactic Shock (1703); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 06/16/2023

Event Type  Injury  

Event Description

It was reported 30 minutes after the cvc was placed in an 81 year old male, the patient's blood pressure dropped to 50/30 and heart rate dropped.Cvc was removed and patient treated with steroids, epinephrine, and fluids.A second cvc was inserted and the patient experienced the same symptoms.Patient returned to normal signs after treatment.The patient's current condition was reported to be stable and he was released from hospital.

Manufacturer Narrative

(b)(4).Associated mdr#s 9680794-2023-00551 and 9680794-2023-00550.

Manufacturer Narrative

(b)(4).Associated mdr#s 9680794-2023-00551 and 9680794-2023-00550.The report of a catheter related allergic reaction was confirmed based on the customer report.The customer report confirmed that the patient experienced anaphylactic shock symptoms due to chlorhexidine exposure.The customer used two different catheters coated in chlorhexidine and the patient experienced the same reaction twice.The labeling provided with the coated catheter states "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." therefore, based on the reported event, unintentional use error (patient condition) likely caused or contributed to this event.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported 30 minutes after the cvc was placed in an 81 year old male, the patient's blood pressure dropped to 50/30 and heart rate dropped.Cvc was removed and patient treated with steroids, epinephrine, and fluids.A second cvc was inserted and the patient experienced the same symptoms.Patient returned to normal signs after treatment.The patient's current condition was reported to be stable and he was released from hospital.

• Brand Name: ARROW PI CVC KIT: 2L 8 FR
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17434054
• MDR Text Key: 320125984
• Report Number: 9680794-2023-00551
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902213829
• UDI-Public: 10801902213829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: ASK-42802-TGH1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male